Device and methods for treating paranasal sinus conditions

• US 8,025,635 B2
• Filed: 04/04/2006
• Issued: 09/27/2011
• Est. Priority Date: 04/04/2005
• Status: Active Grant

• Current Assignee: Intersect ENT, Inc. (Medtronic Plc)
• Original Assignee: Intersect ENT, Inc. (Medtronic Plc)
• Inventors: Eaton, Donald J., Arensdorf, Patrick A., Biggs, Danielle L., Tice, Thomas R., Downie, David B., Brenneman, Rodney
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): MEDWAY, SCOTT J
• Application Number:
  US11/398,342
• Publication Number:
  US 20070005094A1
• Time in Patent Office: 2,002 Days
• Field of Search: 604/101.01, 604/94.01, 604/514, 606/199
• US Class Current: 604/94.01
• CPC Class Codes: A61B 17/24 for use in the oral cavity, larynx, bronchial passages or nose for medical inspection of cavities or tubes in the body A61B1/00; Tongue scrapers
• CPC Class Codes: A61F 2/186 Nose parts
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 47/14 Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61K 9/1647 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61K 9/70 Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug hollow drug-filled fibres A61K9/0092
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61P 27/16 Otologicals
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Described here are paranasal sinus devices for treating paranasal sinus conditions. The devices include a cavity member, ostial member, and nasal portion. One or more of the cavity member, ostial member, and nasal portion may deliver an active agent for sustained release to treat the paranasal sinus condition. Exemplary paranasal sinus conditions are sinus inflammation due to functional endoscopic sinus surgery (FESS) and rhinosinusitis.

Claims

1. A system for treating a paranasal sinus condition comprising:

a) an introducer; and

b) a fully implantable, bioabsorable, paranasal sinus device comprising

a first member and a plurality of prongs, each prong having a proximal end extending from a distal end of the first member and a free distal end, wherein the first member and plurality of prongs are made of a bioabsorbable polymer, and

an active agent configured to release therefrom;

wherein the device has a first configuration wherein the plurality of prongs is collapsed to permit the device to pass through a sinus ostium or surgically created fenestration and a second expanded configuration after placement into a sinus cavity.

2. The system of claim 1 wherein the introducer comprises a conduit having a lumen and a distal portion, and wherein the paranasal sinus device is placed within the lumen or is releasably secured to the distal portion of the introducer.

3. The system of claim 2 further comprising a sheath.

4. The system of claim 3 wherein the paranasal sinus device is delivered into the sinus cavity by retracting the sheath to deploy the first member and expand the plurality of prongs.

5. The system of claim 2 wherein the introducer is preloaded with the paranasal sinus device.

6. The system of claim 1 wherein the paranasal sinus condition is sinus inflammation due to functional endoscopic sinus surgery (FESS).

12. The system of claim 2 wherein the paranasal sinus device is delivered into the sinus cavity by advancing a pusher through the conduit lumen.

13. The system of claim 1 wherein the paranasal sinus device is releasably secured to the introducer.

14. The system of claim 1 wherein the introducer is malleable.

15. The system of claim 1 wherein the paranasal sinus condition is sinus inflammation.

7. A method for treating a paranasal sinus condition comprising:

fully implanting a paranasal sinus device within a patient, wherein the paranasal sinus device comprises

a first member and a plurality of prongs, each prong having a proximal end extending from a distal end of the first member and a free distal end, wherein the first member and plurality of prongs are made of a bioabsorbable polymer,

and an active agent configured to release therefrom;

wherein the plurality of prongs expand to contact surrounding tissue in the paranasal sinus when the device is fully implanted.

8. The method of claim 7 wherein the paranasal sinus device releases the active agent to treat the paranasal sinus condition for about one week.

9. The method of claim 7 wherein the paranasal sinus device releases the active agent to treat the paranasal sinus condition for about two weeks.

10. The method of claim 7 wherein the paranasal sinus device releases the active agent to treat the paranasal sinus condition for about three weeks.

11. The method of claim 7 wherein the paranasal sinus device releases the active agent to treat the paranasal sinus condition for about one month.

16. The method of claim 7 wherein the active agent is included in a coating on the device.

17. The method of claim 16 wherein the plurality of prongs comprises one or more anchoring elements.